Oral Semaglutide Reduces Heavy Drinking in Alcohol Use Disorder: CU Anschutz Clinical Trial Results
Key Insights
An eight-week randomized, double-blind, placebo-controlled trial found oral semaglutide reduced heavy drinking days and alcohol cravings in 50 adults with moderate-to-severe Alcohol Use Disorder (search).
Participants receiving oral semaglutide also showed fewer alcohol-related problems, improved drinking risk level, and reduced cannabis use days compared to placebo.
No new FDA-approved medications for AUD have been approved since 2006, highlighting the significant unmet medical need that oral semaglutide could potentially address.
A clinical trial led by researchers at the University of Colorado Anschutz (search) Medical Campus has found that oral semaglutide, a medication widely used for diabetes and weight loss, significantly reduces heavy drinking in adults with Alcohol Use Disorder (search) (AUD). The study, published in The American Journal of Psychiatry, evaluated the oral formulation of semaglutide, which may offer a more acceptable treatment option for people with AUD compared to the injectable formulations previously tested for this indication.
"This study suggests oral semaglutide may help reduce heavy and harmful drinking, even in people who are not trying to quit alcohol entirely," said Joseph Schacht, PhD, associate professor at the CU Anschutz School of Medicine. "It could represent a new treatment option for AUD, particularly for those who have not benefited from existing medications, and may reduce alcohol-related health and social harms. Importantly, even reducing heavy drinking can lead to meaningful improvements for patients and families."
The Unmet Need in Alcohol Use Disorder
AUD is a chronic medical condition in which individuals have difficulty controlling alcohol use despite harmful consequences. It affects millions of people and remains difficult to treat, with limited medication options available. No new medications have been approved for AUD by the FDA in nearly two decades — the last approval occurred in 2006 — underscoring the urgent need for additional treatment approaches.
"Alcohol Use Disorder (search) can affect nearly every part of life, including physical health, mental health, relationships and safety. Many people do not respond to current treatments, highlighting a significant unmet medical need," Schacht said. "With no new FDA-approved medications for AUD since 2006, identifying new therapeutic options is especially critical. For families, even modest reductions in heavy drinking can mean greater stability, fewer crises and improved quality of life."
Trial Design and Key Findings
The eight-week randomized, double-blind, placebo-controlled trial enrolled 50 adults seeking treatment for moderate-to-severe AUD. Participants receiving oral semaglutide demonstrated a consistent pattern of reductions in harmful real-world drinking behavior across multiple measures:
- Fewer heavy drinking days
- Reduced alcohol consumption per drinking occasion
- Lower day-to-day alcohol cravings
- Fewer alcohol-related problems
- Improved overall drinking risk level
- Reduced cannabis use days
While not all measures changed in controlled laboratory settings, the overall pattern showed consistent reductions in harmful real-world drinking behavior. These findings suggest oral semaglutide may help people reduce harmful drinking even without full abstinence, offer a new treatment option for individuals who do not respond to existing medications, and reduce alcohol-related health, safety, and social harms.
Safety Profile and Tolerability
Oral semaglutide was generally well tolerated in the study, with most side effects reported as mild. Study participants demonstrated high adherence and completion rates, supporting the feasibility of this approach in real-world clinical settings.
Next Steps
Researchers emphasize that larger and longer-term studies are needed to confirm these findings and determine optimal dosing and treatment strategies for Alcohol Use Disorder (search). The study was funded in part by the National Institute on Alcohol Abuse and Alcoholism (search), and CU Anschutz and partner institutions are planning to conduct larger trials soon.